(81 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The KAIYANG Steel Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it The device uses a standard sling type back and seat, the is foldable easily. upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Here's an analysis of the provided text regarding the KAIYANG Steel Wheelchair, structured to address your specific questions.
It's important to note that this document is a 510(k) summary for a Class I medical device (mechanical wheelchair). For this class of device, the regulatory bar for demonstrating safety and effectiveness is generally met by showing substantial equivalence to a predicate device, rather than requiring extensive clinical trials with human readers, pathology, or highly specialized expert consensus panels as might be seen for higher-risk devices or AI algorithms.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC vol. 1 | Meets applicable requirements |
| ISO 7176 Wheelchair Standards | Meets applicable requirements |
Explanation: The KAIYANG Steel Wheelchair states that it "meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." These standards provide the acceptance criteria for mechanical wheelchairs, covering aspects like static, impact, and fatigue strength, braking, stability, and dimensions. The device's performance is reported as compliant with these standards.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the performance testing. Performance testing for mechanical wheelchairs typically involves testing physical units of the device to the specified standards (e.g., loading, impact tests). The provenance of this test data would be from the manufacturer's testing facility (Guangdong Kaiyang Medical Technology Co., Ltd. in China), and it would be prospective in the sense that the manufacturer tested their device against the standards. It's not "data" in the sense of patient records or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to this type of device and submission. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for devices making diagnostic or treatment claims, or those using AI algorithms. For a mechanical wheelchair, the "ground truth" is defined by the objective, measurable parameters outlined in the ANSI/RESNA and ISO standards, which are physical properties and performance metrics. Compliance is assessed through engineering and mechanical testing, not expert medical review of cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods involving multiple experts are used to resolve disagreements in subjective interpretations (e.g., imaging reads). The performance testing for a mechanical wheelchair against a standard is objective mechanical testing, where results are typically pass/fail based on predefined thresholds in the standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study and no AI component in this submission. This type of study is relevant for AI-powered diagnostic or assistive technologies where human performance is part of the evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone algorithm performance study as there is no AI algorithm associated with this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is primarily established by the objective, measurable criteria defined within the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. These standards define acceptable levels of structural integrity, stability, braking performance, dimensions, and other physical requirements for a mechanical wheelchair. Compliance is demonstrated through physical testing against these predefined engineering specifications.
8. The sample size for the training set
There is no training set for this device submission. Training sets are used for machine learning models, which are not involved here.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this device.
Summary of the Study provided:
The primary "study" presented in this 510(k) summary is the performance testing against recognized national and international standards for mechanical wheelchairs (ANSI/RESNA WC vol. 1 and ISO 7176). The document states that the KAIYANG Steel Wheelchair "meets the applicable performance requirements" of these standards.
The core of the K101999 submission is a demonstration of substantial equivalence to existing predicate devices (JMC612-FL318EPP and JMC612-FL418EPP). The comparison highlights identical intended use (mobility for persons restricted to a seated position) and similar structural features (foldable mainframe, removable armrests, swing-away footrest, flame-retardant upholstery). The main difference noted is the material of the frame (steel for the new device and one predicate, aluminum for the other predicate) and overall appearance, which are deemed not to affect safety. The FDA's letter confirms the determination of substantial equivalence.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).